A Double-blinded,Double-dummy Clinical Trial of Chinese Herbal Medicine (MaZiRenWan) for Functional Constipation

May 10, 2020 updated by: ZhaoXiang Bian, Hong Kong Baptist University

Chinese Herbal Medicine (MaZhiRenWan) for Functional Constipation: a Prospective, Double-blinded, Double-dummy, Randomized Controlled Study

The objective of this study is to evaluate the efficacy and safety of a Chinese herbal proprietary medicine, MaZiRenWan (MZRW), by comparing with stimulant laxative western medicine (WM), senna, and placebo for patients with functional constipation (FC) in excessive TCM syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Functional constipation (FC) is a common clinical complaint. Despite the effectiveness of MaZiRenWan (MZRW) for alleviating FC symptoms has been proofed in the previous study.Given the results of the dose determination study and placebo-controlled study of MZRW, we hypothesize that MZRW is more useful than senna (senokot), a commonly used WM drug for constipation, for FC patients in excessive TCM syndrome.This is a prospective, double-blind, double dummy, randomized, controlled trial. After a 2-week run-in, eligible FC patients (Rome III) in excessive TCM syndrome will randomly be assigned to CHM arm (MZRW and WM placebo), WM arm (senna and CHM placebo) or placebo arm (CHM placebo and WM placebo). Patients will undergo an 8-week treatment and an 8-week follow-up.

Study Type

Interventional

Enrollment (Actual)

291

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China
        • School of Chinese Medicine, Hong Kong Baptist University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • either gender aged 18 to 65 years
  • have FC diagnosed as Rome III criterial
  • have diagnosis of Excessive Constipation according to the TCM theory
  • complete spontaneous bowel movement (CSBM) ≦2times/w
  • severity of constipation≧3pts (7 pts scale from 0 to 6pts) and the overall scoring of constipation-related symptoms≧6pts (6items in 7pts scale) for self symptom assessment in the run-in period
  • normal colonic evaluation (colonoscopy or barium enema) within 12 months
  • normal liver and renal function in blood test within 3 months

Exclusion Criteria:

  • drug-induced constipation
  • secondary causes of constipation (i.e. medical history of diabetes mellitus and thyroid disease)
  • abdominal surgery (i.e. Caesarean operation)
  • severe diseases (i.e. cancer and acute present asthma)
  • allergy to CHM (i.e. G6PD deficiency), senna and tartrazine
  • pregnancy or breast-feeding
  • psychiatric or addictive disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MZRW
MZRW is composed of Fructus Cannabis (HuoMaRen), Radix et Rhizoma Rhei (DaHuang), Radix Paeoniae Alba (BaiShao), Semen Armeniacae Amarum (KuXingRen), Fructus Aurantii Immaturus (ZhiShi) and Cortex Magnoliae Officinalis (HouPo).
Drug: MZRW
Patients are instructed to dissolve a sachet of granules (7.5g) in 150ml of hot water; they take this solution orally twice daily for 8 weeks.
Other Names:
  • Hemp Seed Pill
Drug: placebo
The placebo MZRW is made from dextrin (76.03%), tea essence (23.61%), gardenin (0.02%) and caramel (0.34%) to achieve color, smell, taste and texture comparable to MZRW granules.The placebo Senna is made of starch and colour to achieve comparable appearance to Senokot.
Active Comparator: Senna
Senna is a stimulant laxative which facilitates the passage of stools by altering intestinal electrolyte transport and increasing intestinal motor activity.
Drug: placebo
The placebo MZRW is made from dextrin (76.03%), tea essence (23.61%), gardenin (0.02%) and caramel (0.34%) to achieve color, smell, taste and texture comparable to MZRW granules.The placebo Senna is made of starch and colour to achieve comparable appearance to Senokot.
Drug: Senna
Patients are instructed to take 2 tablets at the bedtime for 8 weeks.
Other Names:
  • Senokot
Placebo Comparator: Placebo
Placebo MZRW and Placebo Senna
Drug: placebo
The placebo MZRW is made from dextrin (76.03%), tea essence (23.61%), gardenin (0.02%) and caramel (0.34%) to achieve color, smell, taste and texture comparable to MZRW granules.The placebo Senna is made of starch and colour to achieve comparable appearance to Senokot.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the responder rate for CSBM during the treatment period
Time Frame: 8 weeks
a clinically meaningful endpoint by combining an objective measure (number of bowel movement) with a subjective measure (feelings of patients as to completeness of defecation,Patients with a mean increase of ≧1 complete spontaneous bowel movement(CSBM)/wk compared with the baseline(wk1-2) will be defined as responders
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the responder rate for CSBM during the follow-up period
Time Frame: 8 weeks
Participants with a mean increase of complete spontaneous bowel movement (CSBM)>=1 movement per week compared with the last 14 days of the run-in period were defined as responders
8 weeks
Individual assessment of constipation and related symptoms
Time Frame: 18 weeks
severity of constipation, sensation of straining, incomplete evacuation, bloating, abdominal pain / cramping, nausea, and passing of gas) was recorded using a 7-point ordinal scale (0 = not at all and 6 = very severe
18 weeks
the changes of colonic transit time
Time Frame: 18 weeks
It is estimated by using a commercially available radio-opaque Sitzmarks capsule (Konsyl Pharmaceuticals, US). Each gelatine capsule contained 24 barium sulphate embedded polyvinyl chloride markers measuring 1mmx4.5mm. Plain radiographs of the abdomen will be obtained after the swallow of capsule for five days (120 hours) before and after 8 weeks treatment period.
18 weeks
Global symptom assessment
Time Frame: 18 weeks
Participants were asked to rate their impression of change in constipation by comparing with their baseline (Wk2) at the visits during the treatment (Wk6), end of treatment (Wk10) and end of follow-up (Wk18) with scores from 0 to 6 represented markedly worse or better respectively. The response categories were collapsed to simply "improved" for score 4 to 6, "same" for score 3 or "worse" for score 0 to 2.
18 weeks
Success of blinding
Time Frame: 18 weeks
the success of blinding is evaluated for both investigator and patients as to whether CHM, WM or placebo had been taken
18 weeks
safety profiles
Time Frame: 18 weeks
Assessed by determining the important adverse events reported in the participants ' diaries, follow-up interviews,and clinical laboratory evaluationse.g., liver and renal function.
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hong Kong Baptist University

Collaborators

Queen Elizabeth Hospital, Hong Kong
Prince of Wales Hospital, Shatin, Hong Kong

Investigators

  • Principal Investigator: Zhao Xiang Bian, MD, Ph. D, School of Chinese Medicine, Hong Kong Baptist University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

September 27, 2012

First Submitted That Met QC Criteria

September 27, 2012

First Posted (Estimate)

September 28, 2012

Study Record Updates

Last Update Posted (Actual)

May 12, 2020

Last Update Submitted That Met QC Criteria

May 10, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHSRF09101501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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